ClinicalTrials.Veeva

Menu

Vermont Diabetes Information System

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Other: Information and decision support for providers and patients

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00109369
K24DK068380 (U.S. NIH Grant/Contract)
61167 (completed)
R01DK061167 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. It will be evaluated by a randomized, controlled study in 60 Primary Care practices in Vermont and nearby New York.

Full description

The long-term goal of the Vermont Diabetes Information System is to reduce morbidity and mortality from diabetes mellitus. The project will implement and evaluate a state-wide system to support evidence-based disease management by primary care providers, their practices, and their patients in the community. The primary study question is: "What is the effect of a Diabetes Information System (including education, feedback and decision support) upon disease control measured by glycated hemoglobin?" Secondary questions address the effect of the system upon adherence to guideline recommendations, blood pressure control, patient satisfaction, medication use, and functional status. We hypothesize that the information system will result in improvements in the process and outcomes of clinical care. There are two specific aims:

Aim 1: Implement the Diabetes Information System. Objective 1.1: Develop a registry of patients with diabetes in primary care practices in Vermont; Objective 1.2: Provide education and feedback to providers regarding their patients with diabetes; Objective 1.3: Deliver decision support (flow sheets, alerts and reminders) based on the registry and targeted at primary care providers and patients, to prompt ideal management of diabetes.

Aim 2: Assess the Diabetes Information System. Objective 2.1: Assess disease control and guideline adherence by examining registry data in all subjects in a prospective, two-year, randomized, controlled trial in 60 primary care practices; Objective 2.2: Assess outcomes (blood pressure control, obesity, functional status, symptoms, medication use, and satisfaction) by interview and examination in a sub-sample of patients from the controlled trial.

Enrollment

7,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult
  • Diabetes confirmed by Primary Care provider

Exclusion criteria

  • Severe dementia
  • Nursing home resident

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7,500 participants in 2 patient groups

Active
Experimental group
Description:
Provider and patient receive Diabetes Information System services
Treatment:
Other: Information and decision support for providers and patients
Control
No Intervention group
Description:
Usual Care

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems